The following data is part of a premarket notification filed by Inhalation Plastics with the FDA for Filt-r-all Bacterial Filter.
Device ID | K896832 |
510k Number | K896832 |
Device Name: | FILT-R-ALL BACTERIAL FILTER |
Classification | Filter, Bacterial, Breathing-circuit |
Applicant | INHALATION PLASTICS 7790 N. MERRIMAC Chicago, IL 60648 |
Contact | James Lekkas |
Correspondent | James Lekkas INHALATION PLASTICS 7790 N. MERRIMAC Chicago, IL 60648 |
Product Code | CAH |
CFR Regulation Number | 868.5260 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-12-05 |
Decision Date | 1990-01-22 |